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New in JKS Document Store


Tokyo, September 5, 2003


The "Basics of the Japanese CTD/eCTD" opens the new Milestone series of JKS documents, dedicated to the twelve individual phases of the lifecycle of the regulated medicinal products in Japan. This one is the first of the series and describing the Dossier phase. Full up-to-date description of the basics of the CTD/eCTD as implemented in Japan with references and annotations. 28 pages document.

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For the first time translated into English the full list of the documents released by the Japanese pharmaceutical affairs regulatory authorities between 1st and 30th of June 2003. 25 pages document.

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Enquiries: regulatory(at)


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